TALAZOPARIB TOSYLATE - Generic Drug Details

What are the generic drug sources for talazoparib tosylate and what is the scope of freedom to operate?

Talazoparib tosylate is the generic ingredient in one branded drug marketed by Pfizer and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Talazoparib tosylate has ninety-five patent family members in thirty-one countries.

Two suppliers are listed for this compound.

Summary for TALAZOPARIB TOSYLATE

International Patents:	95
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	10
Patent Applications:	95
DailyMed Link:	TALAZOPARIB TOSYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TALAZOPARIB TOSYLATE

Constraining patent/regulatory exclusivity:

10,189,837

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

10,189,837

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TALAZOPARIB TOSYLATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Stanford University	Phase 2
Roswell Park Cancer Institute	Phase 1
Pfizer	Phase 1

See all TALAZOPARIB TOSYLATE clinical trials

Pharmacology for TALAZOPARIB TOSYLATE

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TALAZOPARIB TOSYLATE

L01XK	Poly (ADP-ribose) polymerase (PARP) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for TALAZOPARIB TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		RX	Yes	No	9,820,985
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-006	Mar 7, 2024		RX	Yes	Yes	10,780,088
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-005	Mar 7, 2024		RX	Yes	No	8,420,650		Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-002	Oct 16, 2018		RX	Yes	Yes	10,189,837		Y	Y
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-001	Mar 7, 2024		RX	Yes	No

International Patents for TALAZOPARIB TOSYLATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3757106	SEL TOSYLATE DE LA (8S,9R)-5-FLUORO-8-(4-FLUOROPHÉNYL)-9-(1-MÉTHYL-1H- 1,2,4-TRIAZOL-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTALAZIN-3(7H)-ONE CRISTALLIN (CRYSTALINE (8S,9R)-5-FLUORO-8-(4-FLUOROPHENYL)-9-(1-METHYL-1H-1,2,4-TRIAZOL-5-YL)-8,9-DIHYDRO-2H-PYRIDO[4,3,2-DE]PHTALAZIN-3(7H)-ONE TOSYLATE SALT)
Portugal	2767537
Lithuania	PA2019522
Spain	2466565
Poland	2767537

Supplementary Protection Certificates for TALAZOPARIB TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2767537	CR 2019 00055	Denmark		PRODUCT NAME: TALAZOPARIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT; REG. NO/DATE: EU/1/19/1377 20190624
2767537	C02767537/01	Switzerland		PRODUCT NAME: TALAZOPARIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67141 12.12.2019
2767537	LUC00140	Luxembourg		PRODUCT NAME: TALAZOPARIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/19/1377 20190624
2767537	PA2019522,C2767537	Lithuania		PRODUCT NAME: TALAZOPARIBAS; REGISTRATION NO/DATE: EU/1/19/1377 20190620
2767537	408 19-2019	Slovakia		OWNER(S): MEDIVATION TECHNOLOGIES LLC, NEW YORK, NY, US; DATUM ZAPISU DO REGISTRA: 20.1.2022

TALAZOPARIB TOSYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Talazoparib Tosylate

Introduction to Talazoparib Tosylate

Talazoparib, marketed as Talzenna, is a small molecule poly (ADP-ribose) polymerase (PARP) inhibitor developed by Pfizer. It is used in the treatment of genetically defined cancers, including breast cancer, prostate cancer, and other indications[4].

Recent Regulatory Approvals

In June 2023, the FDA approved talazoparib in combination with enzalutamide for the treatment of homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). This approval was based on the positive results from the phase 3 TALAPRO-2 trial, which demonstrated a significant improvement in radiographic progression-free survival (rPFS) compared to placebo and enzalutamide[1][2].

Clinical Efficacy and Safety

The TALAPRO-2 trial, a randomized, double-blind, placebo-controlled study, enrolled over 1000 patients with mCRPC. The trial showed that the combination of talazoparib and enzalutamide reduced the risk of disease progression or death by 37% compared to placebo and enzalutamide. The median rPFS was not reached in the experimental arm, indicating fewer participants experienced disease progression or death. Secondary endpoints, including overall survival (OS), objective response rate (ORR), and time to PSA progression, also improved in the talazoparib arm[2].

However, the treatment is associated with several adverse reactions, including anemia, reduced neutrophil and platelet counts, fatigue, and decreased appetite. Serious adverse reactions such as myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) were also reported in a small percentage of patients[1][2].

Market Impact and Growth Potential

The approval of talazoparib for mCRPC is expected to significantly impact the market for prostate cancer treatments. Given that up to 20% of prostate cancer cases progress to mCRPC within 5 to 7 years of diagnosis, the demand for effective treatments is high. The global talazoparib market is anticipated to grow, driven by the increasing incidence of genetically defined cancers and the expanding use of PARP inhibitors in various cancer types[3].

Market Size and Forecast

The global talazoparib market is estimated to grow from 2023 to 2031, with a notable increase in market size and revenue. The market report highlights that the base year for calculations is 2023, and forecasts are provided from 2025 to 2031. The report includes detailed segmentation by type, region, and country, as well as analyses of market trends, drivers, opportunities, and restraints[3].

Regional Dominance

The market is expected to be dominated by regions with high incidence rates of prostate cancer and advanced healthcare infrastructure. The United States, for instance, had approximately 3 million cases of prostate cancer in 2020, making it a significant market for talazoparib[2].

Competitive Landscape

Talazoparib competes in a market with other PARP inhibitors and cancer therapies. However, its unique combination with enzalutamide for mCRPC positions it as a potential new standard of care. Pfizer's strong presence in the oncology market and the drug's efficacy profile are expected to drive market share and revenue growth[2].

Financial Assistance and Access Programs

To support patient access, Pfizer offers various financial assistance and patient support programs through Pfizer Oncology Together. These programs help navigate the access and reimbursement process and provide financial assistance options for patients[5].

Pricing and Cost Considerations

The cost of talazoparib, like other cancer therapies, is significant. The pricing strategy will be crucial in determining the drug's market penetration and patient adherence. While exact pricing details are not provided, the overall cost-effectiveness of the treatment will be a key factor in its adoption by healthcare systems and patients[4].

Adverse Events and Safety Monitoring

Given the serious adverse reactions associated with talazoparib, continuous safety monitoring and reporting are essential. Healthcare professionals are advised to report all serious adverse events to the FDA’s MedWatch Reporting System, ensuring that any safety concerns are promptly addressed[1].

Future Development and Expansion

Talazoparib is being investigated in various other cancer types, including ovarian cancer, endometrial cancer, and solid tumors. These ongoing and future clinical trials will further expand its market potential and contribute to its financial trajectory[4].

Key Takeaways

• Regulatory Approval: FDA approval for talazoparib with enzalutamide in HRR gene-mutated mCRPC.
• Clinical Efficacy: Significant improvement in rPFS and other secondary endpoints.
• Market Growth: Expected growth driven by increasing incidence of genetically defined cancers and expanding use of PARP inhibitors.
• Competitive Landscape: Unique combination with enzalutamide positions it as a potential new standard of care.
• Financial Assistance: Programs available to support patient access and reimbursement.
• Future Development: Ongoing and future clinical trials in various cancer types.

FAQs

1. What is the recent FDA approval for talazoparib?

The FDA approved talazoparib in combination with enzalutamide for the treatment of HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC) in June 2023[1].

2. What are the common adverse reactions associated with talazoparib?

Common adverse reactions include anemia, reduced neutrophil and platelet counts, fatigue, and decreased appetite. Serious adverse reactions such as MDS/AML have also been reported[1][2].

3. How does the combination of talazoparib and enzalutamide impact prostate cancer treatment?

The combination reduces the risk of disease progression or death by 37% compared to placebo and enzalutamide, making it a potential new standard of care for mCRPC[2].

4. What is the market forecast for talazoparib?

The global talazoparib market is expected to grow from 2023 to 2031, driven by the increasing incidence of genetically defined cancers and the expanding use of PARP inhibitors[3].

5. Are there financial assistance programs available for patients taking talazoparib?

Yes, Pfizer offers financial assistance and patient support programs through Pfizer Oncology Together to help patients navigate the access and reimbursement process[5].

Cited Sources:

1. FDA Approves Talazoparib with Enzalutamide for HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer. FDA.
2. FDA Grants Priority Review to New Drug Application for Talazoparib and Enzalutamide in mCRPC. Pharmacy Times.
3. Talazoparib Market Report 2024 (Global Edition). Cognitive Market Research.
4. Talazoparib - Pfizer. AdisInsight - Springer.
5. Access & Patient Support | TALZENNA® (talazoparib). Pfizer Oncology Together.